If you go back to February, when the FDA announced their intention to initiate REMS on certain opiate drugs, you'll notice the drugs on the list are not only highly abused drugs, but also the drugs that under-educated physicians are routinely prescribing inappropriately, which results in nearly killing their patients. From the presentations at the FDA industry meetings, it's very clear they're not focused directly on curbing abuse; they're focused more on assuring safe use. That focus is also why short-acting narcotics were not initially included in the REMS process; the FDA identified increased complications and deaths from extended release drugs, not short-acting drugs.
I can't even count the number of times I've seen someone post on a forum that their PCP or pharmacist told them it was acceptable to cut a fentanyl patch in half or that they could safely take a broken Oxycontin tablet. One perfect example occurred back in February, during a discussion of this whole REMS process , one person (on another board) made a post just lambasting the whole idea; essentially, she said her PCP was doing a great job of managing her pain and what he prescribed was their business, not the FDA's, and they should just butt out. A few days later, her PCP gave her a script
for 50mcg/hr Fentanyl patches, in spite of the fact that she hadn't been on a single narcotic med prior to that (she was previously on gabapentin, valium, and soma). After 9 days in the hospital, with a machine breathing for her part of the time, she decided maybe having her PCP doing pain management wasn't such a great idea.
I don't see anything in the proposed REMS that is unreasonable. In fact, I view most of it as ridiculous that they even have to bring it up. Doctors and other medical professionals
should accomplishing these things without having some elaborate program from the FDA put in place to watch over them. It's sad that physicians aren't taking this initiative on their own. I also think the education/certification requirements will remove the pharmaceutical sales representatives from the physician education role, since that is a direct conflict of interest, and that will certainly benefit patients in the long run.
Presentation slides from industry meetings on 3/2009 said...
Goals of the REMS
To ensure that the benefits of the drugs continue to outweigh the risks through:
– proper patient selection
– minimizing the risk of overdose, both accidental and intentional
– minimizing the risk of abuse
To ensure that prescribers, dispensers, and patients are aware of and understand the risks and appropriate use of these products.
~snip useless table slide~
Elements To Assure Safe Use:
Certification of Healthcare Providers
– Certifications reflect that prescribers are familiar with educational materials, risks of the drug, and conditions for safe use
– They may reflect special training on, for example, risks or monitoring
Prescriber - Training
- proper patient selection appropriate dosing and administration
- opioid abuse, how to identify patients at risk for addiction
- risk of addiction from exposure to opioids
- risk of overdose due to chewing, crushing, or dissolving an extended-release formulation
- product specific risks
Prescriber - Certification
Prescribers have obtained certification by attesting to the following:
– have received and understand the training information
– will require a physician physician-patient agreement form
– will counsel patients on important information including review of the Medication Guide
– will be retrained and recertified periodically
Prescriber-Patient Agreement
Obtained at the time of first prescription and every 12 months, kept in patient chart, documents:
- patients require management of moderate to severe pain by continuous around the clock opioid therapy for an extended period of time
- patients have been counseled about the risks and benefits of the product including the risk of overdose if given to someone for whom it has not been prescribed
- patients have been given and reviewed the Medication Guide
- patients being prescribed higher doses are opioid tolerant
Elements to Assure Safe Use: Cert. of Pharmacy or Healthcare Provider
– Certifications reflect that persons dispensing the drug (e.g., pharmacists or hospital personnel) are familiar with educational materials, risks of the drug, and conditions for safe use
– They may reflect special training on, for example, risks or monitoring